Compounding

Client Handout

Compounding – any manipulation of an FDA-approved drug product beyond that stipulated on the product's label – is needed in veterinary medicine to provide individualized medication for specific patients with special needs not met by FDA-approved drug products. Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug's dosage form to accommodate a specific patient's needs.

Examples of compounding include:

Mixing two injectable drugs

Creating an oral suspension from crushed tablets or an injectable solution

Adding flavoring to a commercially available drug

Compounded preparations can sometimes provide effective therapies for treating painful or life-threatening medical conditions in animal patients. Compounding is a needed tool and provides much-needed therapeutic flexibility for veterinarians, especially considering the wide range of species and breeds veterinarians treat.

However, if done incorrectly or inappropriately, the use of compounded preparations can lead to prolonged treatment needs; adverse events, including treatment failure; liability; or even enforcement action by federal or state authorities.

Compounding should be implemented based on a licensed practitioner's prescription, and only to meet the medical needs of a specific patient.

Are You Playing by the Rules?

What Are the Rules?

Discussion of compounding rules often centers on two issues: compounding from FDA-approved drug products, and compounding from bulk drug substances. Compounding from FDA-approved drug products is legal, as long as FDA's Extralabel Drug Use Rules and all state rules are followed.

Compounding from bulk drug substances is more complex. The FDA asserts that it has jurisdiction to bar any compounding from bulk drug substances, but generally acknowledges that veterinarians sometimes need to use preparations compounded from these ingredients. Compounding: What Are the Rules? provides a deep dive into the rules that you need to follow, whether working with FDA-approved drug products or bulk drug substances. To make certain you understand the rules fully, you might also want to view our recorded webinar, Compounding: Are You Playing By the Rules (available to AVMA members only).

Contact your liability insurance carrier, such as AVMA PLIT, for any questions you have regarding specifics of your liability coverage.

What Is AVMA's Role?

Because compounding is a critical tool for veterinarians, the AVMA works hard to ensure that veterinary concerns are heard and considered in regulatory rule-making and in Congress, and to keep our member veterinarians informed of the rules and compounding best practices.

AVMA communicates frequently with the FDA to safeguard veterinary access to compounded medications and ensure that the needs of veterinarians and our animal patients are protected.

AVMA educates Congress and regulatory agencies that compounding for animals is a complex issue, and that AVMA and our member veterinarians are available for consultation should other parties seek legislative changes.

AVMA cultivates collaborative working relationships with pharmacy organizations, the animal drug manufacturing industry, and other affected stakeholders, building coalitions that advance and protect the interests of veterinarians and animals.

AVMA monitors the courts on issues of regulatory jurisdiction.

Although the FDA has interpreted all compounding from bulk drug substances as being outside of the rules, the agency has recognized that there are circumstances where there is no drug available to treat a particular animal with a particular condition, because either no drug is approved for a specific animal species or no drug is available under the extralabel drug use provisions. In those limited circumstances, FDA acknowledges that an animal medication compounded from bulk drug substances may be an appropriate treatment option.

The FDA published new draft guidance (PDF summary) in 2015 describing conditions under which it generally would not initiate enforcement action against state-licensed pharmacies, licensed veterinarians, and registered “outsourcing facilities.” The AVMA submitted formal comments on that proposal, drawing on input provided by more than 2,000 AVMA members, and making clear that compounding is absolutely necessary for veterinary medicine because of the limited number of FDA-approved drug products for the many species and conditions that veterinarians treat. The FDA later announced that it was withdrawing its draft guidance and would develop a new draft, which it said it would issue for public comment in 2018.

It is not yet known when the FDA will issue its final guidance on compounding animal drugs from bulk drug substances.

AVMA's Advocacy Work Continues

Because of the many species that veterinarians treat, they require access to compounded medications in order to provide the best medical care to their animal patients. In late 2013, a law mandating how compounding for human medicine would be regulated in the United States was passed but it did not address the many concerns and issues facing veterinarians. In response, the AVMA established a task force to lead a national dialogue among veterinarians, pharmacists, drug manufacturers and the FDA with the goal of developing specific recommendations that would result in clearer guidelines and regulations for veterinarians as they look to provide needed medications and the best care for their patients. The AVMA's Board of Directors approved the task force's recommendations in June 2016 and a legislative proposal was distributed for review by stakeholders in March 2017. AVMA is currently considering the feedback received.

In May 2016, FDA published draft Guidance for Industry #230, Compounding Animal Drugs from Bulk Drug Substances. Even with that new draft guidance, the FDA did not change their position that compounding from bulk drug substances is illegal; the draft guidance would simply have allowed compounding from bulk drug substances under enforcement discretion when certain criteria were met. The FDA then withdrew this draft guidance in November 2017 to clarify that the agency does not plan to finalize that draft, but instead intends to issue a new draft for public comment in 2018.

The AVMA remains concerned that veterinarians' ability to create patient-specific prescriptions compounded from bulk drug substances needs greater protection. AVMA will work closely with stakeholders and the FDA to ensure access to these medications. For the latest news around our compounding advocacy work, visit our blog.